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DANZITEN

NDA

NILOTINIB TARTRATE | N219293 | AZURITY PHARMACEUTICALS INC

2 strengths4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents by expiration date

Active (4)Today

2026

2027

2028

2029

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2040

Today

Feb. 18, 2040

Feb. 18, 2040

Feb. 18, 2040

Feb. 18, 2040

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

78 trials from ClinicalTrials.gov — 2 recruiting, 4 active, 45 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid Leukemia NCT03654768	Phase 2	Active	SWOG Cancer Research Network	81	2018-10-24 → 2028-07-01
Efficacy and Safety of TKIs' Withdrawal After a Two-step Dose Reduction in Patients with Chronic Myeloid Leukemia NCT04147533	Phase 2	Active	Masaryk University	150	2020-06-16 → 2026-06
Pembrolizumab and Dasatinib, Imatinib Mesylate, or Nilotinib in Treating Patients With Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease NCT03516279	Phase 2	Active	ECOG-ACRIN Cancer Research Group	40	2019-06-26 → 2031-08-31
Frontline Asciminib Combination in Chronic Phase CML NCT03906292	Phase 2	Active	University of Jena	125	2019-08-19 → 2027-12
Adapting Treatment to the Tumor Molecular Alterations for Patients With Advanced Solid Tumors: MyOwnSpecificTreatment NCT02029001	Phase 2	Recruiting	Centre Leon Berard	900	2014-03 → 2027-10
The Drug Rediscovery Protocol (DRUP Trial)NCT02925234	Phase 2	Recruiting	The Netherlands Cancer Institute	1,550	2016-08 → 2027-12
Nilotinib in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase NCT00905593	—	APPROVED_FOR_MARKETING	Novartis Pharmaceuticals	—	2008-09
A Study That Switched Patients From Imatinib to Nilotinib and Then Was Followed by Treatment Cessation NCT01744665	Phase 2	Completed	Novartis Pharmaceuticals	59	2013-08-12 → 2018-09-29
Molecular Profiling of Advanced Soft-tissue Sarcomas NCT03784014	Phase 3	Completed	Institut National de la Santé Et de la Recherche Médicale, France	603	2019-10-19 → 2026-01-20
Nilotinib + Pegylated Interferon Alpha 2a for Untreated Chronic Phase Chronic Myelogenous Leukemia NCT01294618	Phase 2	Completed	Hospices Civils de Lyon	60	2011-03 → 2013-09

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$13423.64

Highest Price

$16710.80

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
24338-0155-01NILOTINIB 95MG TAB,PACK,28	$16710.80	FSS	Azurity Pharmaceuticals, Inc.	07/31/2026
24338-0155-01NILOTINIB 95MG TAB,PACK,28	$13423.64	Big4	Azurity Pharmaceuticals, Inc.	07/31/2026
24338-0154-01NILOTINIB 71MG TAB,PACK,28	$16710.80	FSS	Azurity Pharmaceuticals, Inc.	07/31/2026
24338-0154-01NILOTINIB 71MG TAB,PACK,28	$13438.42	Big4	Azurity Pharmaceuticals, Inc.	07/31/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

TAPI NL BVNILOTINIB TARTRATE

DMF 372422022

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Apr 20, 2026	SUPPL -6	View Letter (PDF)
Nov 18, 2025	SUPPL -5	View Letter (PDF)
Nov 8, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 71MG BASE

RLD

4 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 7, 2024

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10874671	Feb 18, 2040	—	—	Yes	—	—
11793809	Feb 18, 2040	—	—	Yes	—	—
12403140	Feb 18, 2040	—	—	Yes	—	—
12629369	Feb 18, 2040	—	—	Yes	—	—

#002 — EQ 95MG BASE

RLD

4 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 7, 2024